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Axsome Therapeutics shares pop after FDA awards breakthrough therapy status to its anti-depressant drug

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Shares of Axsome Therapeutics (NASDAQ:AXSM) picked up traction Wednesday after the Food and Drug Administration awarded a breakthrough therapy designation to its treatment for major depressive disorder.

The sought-after marking, granted to the New York company’s AXS-05 oral, investigational NMDA receptor agonist, offers Axsome and other drug companies the chance to accelerate the development and review timelines for promising drugs like AXS-05 when clinical trials suggest they are better than existing therapies for serious conditions.

READ: Axsome Therapeutics extends gains after raising $23.3M to fund late stage depression drug development

The results were met with enthusiasm from investors who pushed up Axsome shares 6% to $15.20 in morning trade Wednesday.

The awarding of a breakthrough designation to AXS-05 stemmed from the success of a Phase 2 trial that demonstrated its ability to significantly reduce depressive symptoms when compared to the anti-depressant bupropion (Wellbutrin).

“There is a significant unmet medical need for new and mechanistically differentiated treatments for depression. We look forward to working closely with the FDA over the coming months to expedite the development of AXS-05 for the treatment of major depressive disorder,” said Dr Herriot Tabuteau, CEO of Axsome, in a statement.

About 6.7% of adults in the US, or roughly 16 million people, each year suffer from major depressive disorder, a chronic disease characterized by low moods which can trigger suicide, according to the National Institutes of Health.

Axsome Therapeutics is a clinical-stage biopharmaceutical company developing therapies for the management of central nervous system disorders for which few treatment options exist.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors


Source: https://www.proactiveinvestors.com/companies/news/217347/axsome-therapeutics-shares-pop-after-fda-awards-breakthrough-therapy-status-to-its-anti-depressant-drug-217347.html


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